Connector for a medical containerr

ABSTRACT

A connector for a medical container comprises a connector element to be attached to the medical container for providing a port to the medical container. The connector element comprises a head section and a pinch-off section adjoining the head section. The head section comprises an opening and the pinch-off section encloses an inner lumen being in fluid connection with the opening of the head section for proving a fluid path through the connector element. The pinch-off section is flexibly deformable for pinching off the fluid path. A closure element is attachable to the head section for closing the opening of the head section, and a pierceable membrane element is held between the head section of the connector element and the closure element. A deflection element extends from the head section towards the inner lumen for deflecting a needle of a delivery device when piercing the membrane element.

The invention relates to a connector for a medical container accordingto the preamble of claim 1.

A connector of this kind comprises a connector element to be attached tothe medical container for providing a port to the medical container. Theconnector element comprises a head section and a pinch-off sectionadjoining the head section, wherein the head section comprises anopening and the pinch-off section encloses an inner lumen being in fluidconnection with the opening of the head section for providing a fluidpath through the connector element. The opening of the head section canbe closed by a closure element which is attachable to the head sectionof the connector element such that, when the closure element is attachedto the head section, the fluid path through the connector element isblocked. A membrane element can be placed in-between the closure elementand the head section of the connector element. The membrane element canbe pierced by a needle of a delivery device, for example a syringe, forinjecting a medical fluid into the medical container or for extracting amedical fluid from the medical container.

The connector, when attached to a medical container, shall allow forfilling the medical container with a medical fluid, for example a fluidfor the parenteral feeding of a patient such as a glucose solution, afat solution or an amino acid solution. The medical container herein maybe filled for example by a medical supplier (which may be the containermanufacturer) or in a pharmacy of a hospital and shall subsequently beprepared such that it can be stored and delivered for a later usage.

For filling the container, as it is described in WO 2004/084793 A1, afilling spike of a filling station may be inserted into the connectorelement prior to attaching the closure element to the connector element.After the filling is completed, the connector element is pinched-off atits pinch-off section such that the fluid path through the connectorelement is closed and fluid cannot exit from the medical containerthrough the connector element. By attaching the closure element to thehead section of the connector element, then, the connector element issealed towards the outside such that the pinching of the pinch-offsection can be released and the medical container can be stored ordelivered to a hospital or the like.

When using the medical container on a patient, the closure element maybe opened, for example by breaking-off a break-off part. A user hencemay access the connector element by piercing the membrane element placedin-between the head section of the connector element and the closureelement using for example a needle of a syringe. In this way, fluid maybe extracted from the medical container, or fluid may be added to themedical container in order to for example add further components such asvitamins or other nutritional components or the like to the fluidcontained in the container.

When piercing the membrane element using a needle, it shall be avoidedthat the needle comes into contact with the pinch-off section of theconnector element, e.g. because the pinch-off section could have areduced wall thickness in order for it to be deformable for pinching offthe connector element. If the needle were to come into contact with thepinch-off section, there may be a risk of damaging the pinch-offsection, possibly rendering the medical container unsterile and henceuseless. It is clear that the invention relates to any kind of pinch-offsection being in the danger to be damaged by the needle. Reasonstherefore may the thickness of the wall, selection of material of thewall or other. The invention will be described by a connector withthinner walls at the pinch-off section in way of example only.

It is an object of the invention to provide a connector for a medicalcontainer which in an easy and cost-efficient manner reduces the risk ofdamaging the pinch-off section of the connector element when piercingthe membrane element by means of a needle.

This object is achieved by means of a connector comprising the featuresof the independed claims.

Accordingly, a deflection element is provided which extends from thehead section towards the inner lumen of the pinch-off section fordeflecting a needle of a delivery device when piercing the membraneelement.

The deflection element serves to guide the needle towards the innerlumen of the pinch-off section when piercing the membrane element bymeans of the needle. The deflection element herein is shaped such thatthe risk for damaging the pinch-off section by means of the needle, whenintroducing it into the connector element, is reduced, in particular inthat the needle is guided such that it would not come into contact withthe walls of the pinch-off section.

In one embodiment, the deflection element reaches into the inner lumenof the pinch-off section. The deflection element hence extends from thehead section and reaches into the inner lumen enclosed by the pinch-offsection. Herein, the deflection element is formed as a comparativelyrigid piece and in particular may be formed in one piece with the headsection. When a needle is inserted into the opening of the head section,it is deflected by the deflection element or is stopped by thedeflection element such that the needle cannot come into contact withthe walls of the pinch-off section.

Although the deflection element may reach into the inner lumen of thepinch-off section, it extends into the inner lumen of the pinch-offsection only that far that a pinching off of the pinch-off section isnot hindered. In particular, the deflection element does not extend intoa region of the pinch-off section in which (typically) a pinching offshall take place.

The deflection element may for example have the shape of a cylindricalpipe. The deflection element extends from the head section and providesa guide for the needle such that the needle cannot come into contactwith walls of the pinch-off section when inserting it into the connectorelement.

In one embodiment, the deflection element, for example having the shapeof a cylindrical pipe, comprises a guide opening through which theneedle may be guided. The guide opening longitudinally extends along aninsertion direction along which the needle of the delivery device can beinserted into the connector element. Along the insertion direction, theguide opening beneficially is aligned with the opening of the headsection of the connector element through which the needle of thedelivery device is inserted into the connector element.

The deflection element, in one embodiment, is arranged at a radialdistance to the walls of the pinch-off section. The deflection element,hence, is arranged radially inside the pinch-off section such that itprovides a guide inside of the pinch-off section. Because the walls ofthe pinch-off section are arranged radially outside of the deflectionelement at a radial distance to the deflection element, a needle guidedby the deflection element cannot come into contact with the walls of thepinch-off section such that the risk for damaging the walls of thepinch-off section when inserting the needle into the connector elementis greatly reduced.

The connector element may for example have the shape of a ship-shapedconus. The connector element hence has a general ship shape andcomprises for example a fastening section which can be insertedin-between foils of the medical container such that the connectorelement via its fastening section can be welded to the foils of themedical container (having the shape of for example a flexible bag).Herein, the fastening section has a rather rigid shape and has anincreased wall thickness in comparison to walls of the pinch-offsection. Because the walls of the pinch-off section have a reduced wallthickness (at least in particular regions), the pinch-off section isflexibly deformable for pinching-off the fluid path through theconnector element after filling the medical container.

The closure element may for example comprise an attachment sectionattachable to the head section of the connector element and a break-offpart connected to the attachment section along a break line along whichthe break-off part can be broken off the attachment section. The closureelement may for example be attached to the connector element afterfilling of the medical container such that, with the closure elementattached, the medical container can be stored or delivered for exampleto a hospital. When a user wants to access the medical container forexample to inject a medical fluid into the medical container or toextract a medical fluid from the medical container, he breaks off thebreak-off part and hence opens the connector element such that themembrane element placed in-between the closure element and the connectorelement is accessible from the outside for piercing it by means of aneedle of a suitable delivery device, for example a syringe or the like.

The idea underlying the invention shall subsequently be described inmore detail with reference to the embodiments shown in the figures.Herein,

FIG. 1 shows a schematic view of a medical container in the shape of athree-chamber flexible bag comprising three connectors;

FIG. 2A shows a front view of a connector element of a connector;

FIG. 2B shows a side view of the connector element;

FIG. 2C shows a top view of the connector element;

FIG. 3A shows a sectional view along line A-A according to FIG. 2A;

FIG. 3B shows a sectional view along line B-B according to FIG. 2B;

FIG. 4A shows a sectional view of the connector element with a closureelement attached to a head section of the connector element; and

FIG. 4B shows the view of FIG. 4A, with a break-off part broken off theclosure element and with a needle of a delivery device inserted into theconnector element.

FIG. 1 shows in a schematic view a medical container 1 in the shape of aflexible bag made of thin, flexible foils welded to each other. Themedical container 1, in the shown embodiment, comprises three chambers10-12 for receiving medical fluids, for example for the parenteralfeeding of a patient. The chambers 10-12 herein may contain differentmedical fluids, for example a glucose solution, a fat solution and anamino acid solution, wherein the chambers 10-12 may be connected viatearable seams which may be torn open to bring the chambers 10-12 influid connection with each other for mixing the different solutions witheach other prior to delivering them to a patient.

Each chamber 10-12 is associated with a connector 2, as shown in FIG. 1.The chambers 10-12 herein are filled via their respective connectors 2,for example by a medical supplier or within a hospital pharmacy or thelike. After the chambers 10-12 have been filled, the connectors 2 areclosed such that the chambers 10-12 are sealed towards the outside andthe medical container can be stored or delivered for use on a patient.The mixing of the different solutions contained in the chambers 10-12then takes place immediately prior to injecting the medical fluid of themedical container 1 to a patient in that a user, for example a nurse,tears open the tearable seams in-between the chambers 10-12 such thatthe solutions contained in the chambers 10-12 can mix within the medicalcontainer 1.

As shown in FIGS. 4A and 4B, each connector 2 comprises a connectorelement 20, a closure element 21 and a membrane element 22 placedin-between the closure element 21 and the connector element 20.

Detailed views of the connector element 20 are provided in FIGS. 2A to2C and 3A and 3B. The connector element 20 comprises a fastening section200 which can be inserted in-between foils of the medical container 1for welding the connector element 20 to the medical container 1. Thefastening section 200 is adjoined by a pinch-off section 201, whichterminates in a head section 202. To the head section 202 the closureelement 21 is attached via an attachment section 210 in a form lockingmanner by engaging with a locking rim 203 of the head section 202.

The closure element 21, when it is attached to the head section 202 ofthe connector element 20, closes off an opening 204 in the head section202. The closure element 21 comprises a head section 211 adjoining theattachment section 210 and being connected, in the state of FIG. 4A, toa break-off part 214 along a circumferential break line 213.

For manufacturing the medical container 1, the connector elements 20 ofthe connectors 2 are placed in-between the foils of the medicalcontainer 1 and are welded to the foils when forming the chambers 10-12of the medical container 1. After completion of the manufacturing, thechambers 10-12 of the medical container 1 are filled for example by amedical supplier or in a pharmacy of a hospital by inserting a fillingspike into the respective connector elements 20 and by filling thechambers 10-12 with medical solutions as desired.

Once a chamber 10-12 has been filled, the respective connector element20 is pinched-off at its pinch-off section 201 by applying a suitableclamping device. For this, the connector element 20 is flexiblydeformable at its pinch-off section 201, which comprises a reduced wallthickness W1 in comparison to other sections of the connector element20, for example in comparison to a wall thickness W2 of the walls 208 ofthe fastening section 201, as depicted in FIG. 3A.

By pinching off the connector element 20 at its pinch-off sections 201,a fluid path through the connector element 20 is blocked in that aninner lumen L enclosed by the pinch-off section 201 is pinched-off.Subsequently, the closure element 21 can be attached to the head section202 of the connector element 20 for closing the connector element 20,and the pinching of the pinch-off section 201 can be released.

After all chambers 10-12 have been filled and respective closureelements 21 have been attached to the connector elements 20 of theconnectors 2, the medical container 1 can be stored or can be deliveredto a place of usage, for example to a hospital.

Once the medical solution contained in the medical container 1 shall beadministered to a patient, a user may break off one or multiple of thebreak-off parts 214 of the closure elements 21 of the connectors 2 andmay insert a needle 30 of a suitable delivery device 3, for example asyringe, into an opening 212 within the head section 211 of the closureelement 21 and may pierce the membrane element 22 held in-between theclosure element 21 and the connector element 20. By piercing themembrane element 22 by means of the needle 30 and by inserting theneedle 30 in an insertion direction I into the connector element 20through the opening 204 of the head section 202 of the connector element20, a medical fluid may be added to the medical container 1 or a medicalfluid may be extracted from the medical container 1. For example, if themedical container 1 comprises different solutions for the parenteralfeeding of a patient, further components such as vitamins or the likemay be added via one of the connectors 2 prior to administering the(mixed) solutions to a patient.

The membrane element 22 is constituted as a self-sealing membrane which,after removing the needle 30 of the delivery device 3, seals itself suchthat the connector element 20 is closed in a fluid-tight manner towardsthe outside.

When inserting the needle 30 of the delivery device 3 through the headsection 202 of the connector element 20 towards the inner lumen Lenclosed by the pinch-off section 201, it shall be avoided that theneedle 30 pierces the walls 207 of the pinch-off section 201 (having areduced wall thickness W1 as shown in FIG. 3A). For this, a deflectionelement 205 having the shape of a cylindrical pipe is provided whichextends from the head section 202 towards the inner lumen L of thepinch-off section 201, as shown in the sectional views of FIGS. 3A and3B. The deflection element 205 comprises a longitudinal guide opening206 which is aligned along the insertion direction I with the opening204 of the head section 202 such that the needle 30 of a delivery device3 is guided via the deflection element 205 towards the inner lumen L ofthe pinch-off section 201, as shown in FIG. 4B.

The deflection element 205 in the shape of a cylindrical pipe is formedin one piece with the connector element 20 and has a rigid shape suchthat a needle 30 pinching onto the inner circumferential face of theguide opening 206 is deflected and guided in the insertion direction Ior is stopped such that it cannot come into contact with the outer walls207 of the pinch-off section 201. Hence, the risk that the walls 207 ofthe pinch-off section may be damaged by the needle 30 is reduced.

The deflection element 205 extends from the head section 202 in theinsertion direction I and reaches into the inner lumen L of thepinch-off section 201. It herein is placed inside the pinch-off sectionat a radial distance to the walls 207.

Although the deflection element 205 reaches into the inner lumen L ofthe pinch-off section 201, it does not extend through the pinch-offsection 201 and in particular reaches into the inner lumen L only thatfar that a reliable pinching of the pinch-off section 201 is nothindered.

The connector element 20, as visible from the top view of FIG. 2C, hasthe general shape of a ship, with the fastening section 200 reducing inwidth towards both sides along a horizontal direction H such that thefastening section 200 may be reliably welded to the foils of the medicalcontainer 1 for providing a fluid-tight transition. The pinch-offsection 201 likewise does not have a circular cross-section, but isformed such that it may be reliably pinched-off in a pinch-off directionP (see FIG. 3A) for closing off the fluid path through the connectorelement 20, as it is described for example in WO 2004/084793 A1.

The invention is not limited to the embodiments described above, but maybe implemented in an entirely different fashion.

In particular, the invention is not limited to three-chamber medicalbags, but may be applied to any sort of medical containers, having one,two or more chambers.

The medical container not necessarily is flexible, but may also have arigid shape, such as the shape of a bottle or the like.

Each chamber of the medical container may be provided with one, two ormore connector(s) according to the present invention. It is alsounderstood that the medical container may provided with a mixture ofboth, inventive connector(s) and connector(s)/port(s) of the prior art,depending of the needs for the use of said container.

LIST OF REFERENCE NUMERALS

-   1 Medical container (bag)-   10-12 Chamber-   2 Connector-   20 Connector element-   200 Fastening section-   201 Pinch-off section-   202 Head-   203 Locking rim-   204 Opening-   205 Deflection element-   206 Guide opening-   207, 208 Walls-   21 Closure element-   210 Attachment section-   211 Head section-   212 Opening-   213 Break line-   214 Break-off part-   22 Membrane-   3 Delivery device-   30 Needle-   H Horizontal direction-   I Insertion direction-   L Inner lumen-   P Pinch-off direction-   W1, W2 Wall thickness

1-8. (canceled)
 9. A connector for a medical container, comprising: aconnector element to be attached to the medical container for providinga port to the medical container, the connector element comprising a headsection and a pinch-off section adjoining the head section, wherein thehead section comprises an opening and the pinch-off section encloses aninner lumen being in fluid connection with the opening of the headsection for providing a fluid path through the connector element, thepinch-off section being flexibly deformable for pinching off the fluidpath through the connector element, a deflection element extending fromthe head section towards the inner lumen of the pinch-off section fordeflecting a needle of a delivery device when piercing the membraneelement wherein the deflection element reaches into the inner lumen ofthe pinch-off section.
 10. The connector according to claim 9, whereinsaid connector further comprises, a closure element attachable to thehead section of the connector element for closing the opening of thehead section, and a membrane element being pierceable by a needle of adelivery device for injecting a medical fluid into the medical containeror for extracting a medical fluid from the medical container.
 11. Theconnector according to claim 9, wherein the deflection element has theshape of a cylindrical pipe.
 12. The connector according claim 9,wherein the deflection element comprises a guide opening which isaligned with the opening of the head section along an insertiondirection along which the needle of the delivery device is insertableinto the opening of the head section.
 13. The connector according claim9, wherein the deflection element is arranged radially inside thepinch-off section at a distance to walls forming the pinch-off section.14. The connector according to claim 9, wherein the connector elementhas the shape of a ship-shaped conus.
 15. The connector according toclaim 9, wherein the connector element comprises a fastening section tobe fastened to the medical container, wherein walls of the pinch-offsection have a reduced wall thickness in comparison to walls of thefastening section.
 16. The connector according to claim 9, wherein theclosure element comprises an attachment section attachable to the headsection of the connector element and a break-off part connected to theattachment section along a break line along which the break-off part canbe broken off the attachment section.
 17. The connector according toclaim 10, wherein the deflection element has the shape of a cylindricalpipe.
 18. The connector according claim 10, wherein the deflectionelement comprises a guide opening which is aligned with the opening ofthe head section along an insertion direction along which the needle ofthe delivery device is insertable into the opening of the head section.19. The connector according claim 10, wherein the deflection element isarranged radially inside the pinch-off section at a distance to wallsforming the pinch-off section.
 20. The connector according to claim 10,wherein the connector element has the shape of a ship-shaped conus. 21.The connector according to claim 10, wherein the connector elementcomprises a fastening section to be fastened to the medical container,wherein walls of the pinch-off section have a reduced wall thickness incomparison to walls of the fastening section.
 22. The connectoraccording to claim 10, wherein the closure element comprises anattachment section attachable to the head section of the connectorelement and a break-off part connected to the attachment section along abreak line along which the break-off part can be broken off theattachment section.
 23. The connector according claim 11, wherein thedeflection element comprises a guide opening which is aligned with theopening of the head section along an insertion direction along which theneedle of the delivery device is insertable into the opening of the headsection.
 24. The connector according claim 12, wherein the deflectionelement is arranged radially inside the pinch-off section at a distanceto walls forming the pinch-off section.
 25. The connector according toclaim 12, wherein the connector element has the shape of a ship-shapedconus.
 26. The connector according to claim 12, wherein the connectorelement comprises a fastening section to be fastened to the medicalcontainer, wherein walls of the pinch-off section have a reduced wallthickness in comparison to walls of the fastening section.
 27. Theconnector according to claim 12, wherein the closure element comprisesan attachment section attachable to the head section of the connectorelement and a break-off part connected to the attachment section along abreak line along which the break-off part can be broken off theattachment section.
 28. The connector according to claim 12, wherein thedeflection element has the shape of a cylindrical pipe.